Takeda
Associate Director, Global Clinical Supply Chain Operations
Takeda, Lexington, Massachusetts, United States, 02173
Associate Director, Global Clinical Supply Chain Operations
Join Takeda in Cambridge, MA as an Associate Director in Global Clinical Supply Chain Operations. This patient‑focused, innovation‑driven role empowers you to shine while supporting global R&D clinical trials.
POSITION OBJECTIVES
Lead and execute GCSC activities worldwide under the direction of the GCSC Director.
Manage Clinical Supply project delivery for Takeda Global R&D Clinical Trials and other research needs.
Coordinate, procure and manage drug product supply, packaging, labeling, distribution, return, reconciliation, and destruction activities of clinical trial material.
Develop and communicate clinical supply project budgets and plans to ensure all project objectives are met timely and compliant.
Provide expertise, collaborate internally, and lead Global Clinical Supply Chain group initiatives including active participation of the study oversight process.
POSITION ACCOUNTABILITIES
Interpret clinical trial drug requests and clinical protocols with GCSC Planning to develop supply packaging strategies, timelines, and budgets.
Utilize the Smart Supplies Database (PMD) for clinical labeling approval and manage inventory, shipments, and drug return activities.
Provide input into Interactive Response Technology (IRT) design for randomization and supply drug to depots and sites.
Interface with QA/QP personnel to facilitate expeditious release of clinical trial material for shipment to sites.
Interface with Pharmaceutical Sciences group to ensure supplies are supported with stability programs and expiry dating.
Collaborate with Logistics to plan, document, and facilitate global cross‑border supply strategies for controlled substances and regulatory requirements.
Manage and troubleshoot shipment requests, drug returns, SmartSupplies, and IRT processes with GCSC Specialists and maintain project documentation.
Oversee primary and secondary packaging, labeling, testing, distribution, return drug management activities with service providers per approved budget.
Key interface with Clinical Operations and Regulatory Affairs on information required for Health Authority Submissions.
Evaluate and propose system improvements and technology enhancements/opportunities.
Manage external consultants and third‑party vendors to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements.
Accountable for amending budgets through defined change management processes and manage finance activities with clinical team.
Coach and mentor less experienced staff.
Implement improvement opportunities and business processes related to the Clinical Supplies Team.
Manage specialized or high‑profile projects and serve as backup to the director when needed.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
Degree in Pharmacy, other scientific/technical degree, or significant job‑related experience.
Minimum of 8 years relevant Pharmaceutical Industry and/or Contract/Service Provider experience preferred.
Experience with oncology a plus.
Strong understanding of cGMP requirements.
Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software a plus.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Location Lexington, MA
Takeda Compensation and Benefits Summary U.S. Base Salary Range:
$153,600.00 - $241,340.00
The estimated salary range reflects an anticipated range for this position.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
U.S. based employees may be eligible for short‑term and/or long‑term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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POSITION OBJECTIVES
Lead and execute GCSC activities worldwide under the direction of the GCSC Director.
Manage Clinical Supply project delivery for Takeda Global R&D Clinical Trials and other research needs.
Coordinate, procure and manage drug product supply, packaging, labeling, distribution, return, reconciliation, and destruction activities of clinical trial material.
Develop and communicate clinical supply project budgets and plans to ensure all project objectives are met timely and compliant.
Provide expertise, collaborate internally, and lead Global Clinical Supply Chain group initiatives including active participation of the study oversight process.
POSITION ACCOUNTABILITIES
Interpret clinical trial drug requests and clinical protocols with GCSC Planning to develop supply packaging strategies, timelines, and budgets.
Utilize the Smart Supplies Database (PMD) for clinical labeling approval and manage inventory, shipments, and drug return activities.
Provide input into Interactive Response Technology (IRT) design for randomization and supply drug to depots and sites.
Interface with QA/QP personnel to facilitate expeditious release of clinical trial material for shipment to sites.
Interface with Pharmaceutical Sciences group to ensure supplies are supported with stability programs and expiry dating.
Collaborate with Logistics to plan, document, and facilitate global cross‑border supply strategies for controlled substances and regulatory requirements.
Manage and troubleshoot shipment requests, drug returns, SmartSupplies, and IRT processes with GCSC Specialists and maintain project documentation.
Oversee primary and secondary packaging, labeling, testing, distribution, return drug management activities with service providers per approved budget.
Key interface with Clinical Operations and Regulatory Affairs on information required for Health Authority Submissions.
Evaluate and propose system improvements and technology enhancements/opportunities.
Manage external consultants and third‑party vendors to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements.
Accountable for amending budgets through defined change management processes and manage finance activities with clinical team.
Coach and mentor less experienced staff.
Implement improvement opportunities and business processes related to the Clinical Supplies Team.
Manage specialized or high‑profile projects and serve as backup to the director when needed.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
Degree in Pharmacy, other scientific/technical degree, or significant job‑related experience.
Minimum of 8 years relevant Pharmaceutical Industry and/or Contract/Service Provider experience preferred.
Experience with oncology a plus.
Strong understanding of cGMP requirements.
Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software a plus.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Location Lexington, MA
Takeda Compensation and Benefits Summary U.S. Base Salary Range:
$153,600.00 - $241,340.00
The estimated salary range reflects an anticipated range for this position.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
U.S. based employees may be eligible for short‑term and/or long‑term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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